Improving Executive Function in Korean Children With Autism

NCT ID: NCT06523660

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-11
• Study Completion Date: 2026-06-30

Brief Summary

The purpose of this randomized controlled study is to evaluate the acceptability, feasibility, and preliminary efficacy of an executive function (EF) training intervention for 5- to 7-year-old autistic children in South Korea. This study will have three aims: (1) to assess the acceptability and feasibility of the EF intervention with children with ASD; (2) to examine clinically important effects of the intervention using multimodal methods combining lab-based behavioral tasks and novel electrophysiological measures; and (3) to determine whether the effects are generalized to everyday EF skills in real-world settings using parent-ratings.

Detailed Description

The ability to self-monitor and flexibly adapt behavior in response to internal or external changes refers to neurocognitive processes known as executive function (EF). EF impairments, such as inflexible problem-solving, attention-shifting difficulties, and challenges in goal-directed behavior planning, are consistently identified as core cognitive deficits in autism spectrum disorder (ASD). Early life EF deficits can lead to negative social and academic outcomes, including poor school performance, externalizing behaviors, antisocial conduct, and adverse adult outcomes. Therefore, EF has become a significant focus for interventions, yet few studies have investigated EF interventions in ASD. Evidence-based interventions targeting EF are critically needed.

The purpose of this randomized controlled study is to evaluate the effectiveness of an online EF training intervention for 5- to 7-year-old children with ASD in South Korea, where intervention services, especially during school transition periods, are extremely limited. The project has three scientific goals: (1) assess the acceptability and feasibility of the EF intervention for children with ASD; (2) examine the clinically important effects of the intervention using multimodal methods combining lab-based behavioral tasks and novel electrophysiological measures; and (3) determine whether the effects generalize to everyday EF skills in real-world settings using parent-ratings.

The investigators will recruit 40 Korean children with ASD during school transition (20 randomly assigned to the intervention, 20 to the control). Children in the intervention group will participate in a 10-week online training program and will be administered outcome measures, including physiological measures, lab-based behavior, and parent-reports of clinical functioning, at three time points (i.e., pre-intervention, 1-week after the completion of the intervention, and 3-months after the completion of the intervention). Parent coaching will be provided to enhance the generalization of EF skills. The control group will receive group-based parent psychoeducation. This work has the potential to significantly improve EF skills and functional outcomes for autistic children, addressing the urgent need for targeted interventions for the underserved population in South Korea.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Children will receive the EF training intervention, which will be delivered in a telehealth format across 10 sessions (1 1-hour session per week for 10 weeks), targeting core EF components including inhibitory control, attention shifting, and working memory. Accompanied parent coaching will be provided to enhance children's generalization of EF skill attainment.

Group Type: EXPERIMENTAL

CHUCK CHUCK SKILLS: CHild's Understanding of Cognitive sKills

Intervention Type: BEHAVIORAL

The intervention will consist of an online EF training that will be delivered across 10 sessions (one 1 hour session per week for ten weeks). It will target core EF components including inhibitory control, attention shifting, and working memory in children with Autism Spectrum Disorder aged 5 to 7 years. It will also provide strategies (e.g., behavioral principles, compliance training) for promoting behavioral regulation and emotion regulation in these children. Accompanied parent coaching will be provided to enhance children's generalization of EF skill attainment.

Control Group

Group-based parent psychoeducation will be provided to the control group. This program will also be delivered in a telehealth format across 10 sessions (1 1-hour session per week for 10 weeks) and will cover a broad range of information relevant to ASD.

Group Type: ACTIVE_COMPARATOR

Parent Psychoeducation

Intervention Type: BEHAVIORAL

Group-based parent psychoeducation, which consists of 10 sessions, 1-hour weekly program delivered via telehealth, will be provided to the control group.

Interventions

CHUCK CHUCK SKILLS: CHild's Understanding of Cognitive sKills

The intervention will consist of an online EF training that will be delivered across 10 sessions (one 1 hour session per week for ten weeks). It will target core EF components including inhibitory control, attention shifting, and working memory in children with Autism Spectrum Disorder aged 5 to 7 years. It will also provide strategies (e.g., behavioral principles, compliance training) for promoting behavioral regulation and emotion regulation in these children. Accompanied parent coaching will be provided to enhance children's generalization of EF skill attainment.

Intervention Type: BEHAVIORAL

Parent Psychoeducation

Group-based parent psychoeducation, which consists of 10 sessions, 1-hour weekly program delivered via telehealth, will be provided to the control group.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Previous medical diagnosis of ASD, confirmed by Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
• Non-verbal IQ (NVIQ) equal to or above 85
• Verbal children (with flexible phrases or complex sentences)

Exclusion Criteria

• NVIQ below 85
• Presence of medical disorders or injuries with implications for the central nervous system or that require medications that alter EEG processes such as anticonvulsants
• Presence of significant sensory or motor impairment
• Presence of major physical anomalies

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Foundation of Korea

OTHER

Sponsor Role: collaborator

Korea University

OTHER

Sponsor Role: lead

Responsible Party

So Hyun Kim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

So Hyun Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University

Boin Choi, PhD

Role: STUDY_DIRECTOR

Korea University

Locations

Korea University

Seoul, , South Korea

Countries

South Korea

Other Identifiers

00209635

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-2024-0026

Identifier Type: -

Identifier Source: org_study_id